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NCT Number: NCT06064448

Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction

Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP/CPPS with erectile dysfunction.

Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted.

Interventions:

① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously.

③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.

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Key information

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Prostatic Diseases Prostatitis Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 671013, China

About this study

Sample size: 214

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients aged 20-50 years;
  • Have a fixed sexual partner and have a normal sexual life;
  • Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4), or accompanied by lower urinary tract symptoms (micturition score > 4), lasting more than 3 months;
  • Secondary patients with erectile dysfunction after normal erection or sexual intercourse, and IIEF-5 ≤ 21 points;
  • It accords with the main symptoms of damp-heat stagnation syndrome in traditional Chinese medicine;
  • Volunteer subjects and agree to sign informed consent.

Exclusion criteria

  • Those who use any antibiotics, α-receptor blockers, PDE5 inhibitors and androgens within one week;
  • Patients with varicocele or tumors in prostate, bladder and urethra;
  • Have received TURP, TUIP, bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
  • Patients with severe organic ED, drug-induced and traumatic ED, abnormal development of external genitalia or abnormal sex hormone level;
  • Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis;
  • Those who are known to be allergic to the drugs tested in this study or some of their components

Treatment and study plan

Sildenafil

Drug

Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

Other names: Western Medicine Section

Ningmitai capsule

Drug

The subjects took Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, after meals, and continued to treat for 4 weeks.

Other names: Traditional Chinese medicine group

Ningbitai capsule + sildenafil

Drug

The subjects took Ningmitai capsule orally, 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals. Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.

Other names: Combined group

Primary outcomes

  1. The response rate of patients at 4 weeks of treatment.

    Time frame: Treatment for 4 weeks

    The response rate is defined as the proportion of patients whose NIH-CPSI pain score decreased by at least 4 points and IIEF-5 score or EHS score increased at 4 weeks of treatment.

Secondary outcomes

  1. NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment

    Time frame: Treatment for 2 and 4 weeks

    National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.

  2. At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.

    Time frame: Treatment for 2 and 4 weeks

    Change value = IIEF-5 score after treatment-baseline IIEF-5 score IIEF-5 contains five questions about erectile status, confidence in maintaining erection and satisfaction with sexual intercourse, and is widely used to diagnose ED, judge the severity of ED and evaluate the effectiveness of drug treatment for ED. Total score 25 points, the lower the score, the more serious the symptoms.

  3. The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment

    Time frame: Treatment for 2 and 4 weeks

    Erectile hardness score (EHS) is a commonly used method to evaluate the severity of ED in clinic. They are divided into grade I (severe ED), grade II (moderate ED), grade III (mild ED) and grade IV (normal erectile function).

Sponsors and collaborators

Lead sponsor

Xintian Pharmaceutical

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized, Parallel and Positive Drug-controlled Clinical Study of Ningbitai Capsule in the Treatment of Chronic Pelvic Pain Syndrome With Erectile Dysfunction

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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